Exploration of the Potential of Urinary Nerve Growth Factor (NGF) as a Biomarker for Diagnosis and Prognosis of Mixed Urinary Incontinence After Midurethral Slings
Sponsor study identifier
interventional
137
1 country
2
Study Start
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2015
Actual (reported)Study Completion
January 2016
Actual (reported)Female urinary incontinence (UI) can be caused by pure stress UI (SUI), pure urgency UI (UUI) and mixed SUI and UUI (MUI). Clinically it might not be that easy to separate MUI and SUI. Patients might perceive urgency when they have an incompetent urethra and a full bladder. Urinary tract nerve growth factor (NGF)is produced by bladder urothelium and smooth muscle. Increased levels of NGF have been reported in the bladder tissue and urine of patients with overactive bladder (OAB). If the urinary levels of NGF differ among women with pure SUI and MUI, then urinary NGF level might be a biomarker in the differential diagnosis of MUI in women. Also, decreased urinary NGF level was reported in OAB patients of whom the symptoms were improved. So, we might expect that the remnant OAB symptom including urgency incontinence can be improved, if the urinary NGF levels decrease after midurethral slings for SUI in MUI patients. We aimed to explore the value of the urinary NGF as a biomarker for differential diagnosis and as a prognostic marker for predicting the improvement of OAB symptom after midurethral slings.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
December 14, 2011
Actual (reported)December 16, 2011
Actual (reported)October 2015
Actual (reported)January 2016
Actual (reported)Difference in the baseline urinary NGF level between patients with and without urgency incontinence at 6 months after midurethral slings
6 months after midurethral slings
Baselinec cut-off value of urinary NGF level which can predict the patients whose urgency incontinence will be cured and whose urgency incontinence will not be cured.
6 months after midurethral slings
Difference in urinary NGF level between pure SUI and MUI patients
Baseline
Changes in OAB symptoms (including urgency incontinence) and SUI after midurethral slings
2 and 6 months after midurethral slings
Correlation between changes in urinary NGF and OAB symptoms (including urgency incontinence) after midurethral slings
2 and 6 months after midurethral slings
Currently available midurethral procedures for stress urinary incontinence can be used.
Retropubic, Transobturator, and Single incision MUS can be used.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Catholic University of Korea College of Medicine, Bucheon St. Mary's Hospital
Bucheon-si, 420-717, South Korea
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135-710, South Korea
Kyu-Sung Lee, Ph.D
Samsung Medical Center
137 participants (actual enrollment reported by the registry).
First Submitted
December 14, 2011
First Posted
December 16, 2011
Study Start
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 2015
Actual (reported)Study Completion
January 2016
Actual (reported)Last Updated
December 2, 2019
Record last verified: 2019-11
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Source: ClinicalTrials.gov.
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